Clinical testing of MSC in GVHD

Clinical testing of MSC in Graft Versus Host Disease (GVHD)

Joanne Kurtzberg1,*, Hisham Abdel-Azim2, Paul Carpenter3, Sonali Chaudhury4, Biljana Horn5, Kris Mahadeo6, Eneida Nemecek7, Steven Neudorf8, Vinod Prasad1, Susan Prockop9, Troy Quigg10, Prakash Satwani11, Annie Cheng12, Elizabeth Burke12, Jack Hayes12, Donna Skerrett12 for the MSB-GVHD001/002 Study Group

A Phase 3, Single-Arm, Prospective Study of Remestemcel-L, Ex Vivo Culture-Expanded Adult Human Mesenchymal Stromal Cells for the Treatment of Pediatric Patients Who Failed to Respond to Steroid Treatment for Acute Graft-versus-Host Disease. Biology of Blood and Marrow Transplantation

Published: 2020

Clinicaltrials.gov (21. 3. 2020)

Status	Study Title	Conditions	Interventions	Locations
Completed	Allogenic Bone Marrow Mesenchymal Stem Cells Infusion in Patients With Steroid-refractory GVHD	Graft Versus Host Disease	Biological: Mesenchymal Stem Cells	Armed Forces Bone Marrow Transplant Centre Rawalpindi, Punjab, Pakistan
Unknown ^†	Mesenchymal Stem Cells for Treatment of Refractory Acute Graft-versus-host Disease	Acute Graft-versus-host Disease	Biological: Mesenchymal stem cells Biological: Non-mesenchymal stem cells	Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou, Guangdong, China
Unknown ^†	Mesenchymal Stem Cells for Treatment of Refractory Chronic Graft-versus-host Disease	Chronic Graft-versus-host Disease	Biological: Mesenchymal stem cells Biological: Non-mesenchymal stem cells	Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou, Guangdong, China
Completed	Treatment of Refractory Acute Graft-Versus-Host Disease by Sequential Infusion of Allogenic Mesenchymal Stem Cell.	Chronic Graft-Versus-Host Disease	Genetic: Allogenic Mesenchymal Stem Cell	Grupo Espanol de trasplantes hematopoyeticos y terapia celular Madrid, Spain
Completed	Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease	Graft Versus Host Disease	Biological: Mesenchymal Stem Cells Biological: placebo	University of Alabama at Birmingham Birmingham, Alabama, United States Arizona Cancer Center Tucson, Arizona, United States City of Hope Duarte, California, United States (and 67 more…)
Unknown ^†	Evaluation of the Role of Mesenchymal Stem Cells in the Treatment of Graft Versus Host Disease	Graft vs Host Disease	Drug: Mesenchymal Stem Cell Infusion	Department of Haematology, Christian Medical College Vellore, Tamil Nadu, India
Unknown ^†	Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell	Graft-vs-Host Disease (GVHD)	Procedure: Mesenchymal stem cell (MSC)	University Clinic of Navarra Navarra, Pamplona, Spain Santa Creu i Sant Pau Hospital Barcelona, Spain Clinic i Provincial Hospital Barcelona, Spain University Hospital of Salamanca Salamanca, Spain
Unknown ^†	Safety and Efficacy Study of Allogenic Mesenchymal Stem Cells to Treat Extensive Chronic Graft Versus Host Disease	Graft Versus Host Disease	Biological: Mesenchymal stem cell (MSC) Drug: Prednisone and cyclosporine or primary therapies	Guangdong General Hospital Guangzhou, Guangdong, China
Unknown ^†	Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Chronic Graft Versus Host Disease	Chronic Graft Versus Host Disease	Biological: Biological: mesenchymal stem cell Drug: Cyclosporine and Glucocorticoid	Zhejiang University Hangzhou, Zhejiang, China
Completed	Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)	Graft Vs Host Disease	Drug: Prochymal – 2 million cells Drug: Prochymal – 8 million cells	St. Francis Hospital Indianapolis, Indiana, United States Kansas City Cancer Centers – BMT Kansas City, Missouri, United States The Cancer Center at Hackensack University Hackensack, New Jersey, United States (and 6 more…)
Recruiting	Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function	Graft-versus-host Disease Poor Graft Function Low Donor T-cell Chimerism	Biological: Mesenchymal stem cells	UZA Edeghem, Antwerpen, Belgium Hôpital des enfants Reine Fabiola Brussels, Brabant, Belgium AZ VUB Jette Brussels, Brabant, Belgium (and 9 more…)
Unknown ^†	Umbilical Cord Blood-derived Mesenchymal Stem Cells for the Treatment of Steroid-refractory Acute or Chronic Graft-versus-host-disease	Graft-Versus-Host Disease GVHD Allogeneic Hematopoietic Transplant Disorder Related to Transplantation	Biological: Human umbilical cord blood-derived mesenchymal stem cells	Department of Pediatrics, Samsung Medical Center Seoul, Korea, Republic of
Completed	Multicenter Clinical Trial for the Evaluation of Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.	Graft Versus Host Disease Chronic and Expanded Graft Versus Host Disease Immune System Diseases	Other: Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.	Hospital de Jerez de la Frontera. Jerez de la Frontera, Cádiz., Spain Hospital Universitario Virgen de las Nieves Granada., Spain Hospital Universitario Virgen del Rocío de Sevilla Sevilla, Spain Hospital Clínico de Valencia Valencia, Spain
Unknown ^†	Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation	Graft-versus-host Disease Relapse	Biological: Mesenchymal stem cells	BMT department Moscow, Russian Federation
Unknown ^†	Allogeneic Mesenchymal Stem Cell for Graft-Versus-Host Disease Treatment	Graft-Versus-Host Disease	Procedure: MSC transplantation	Hadassah University Hospital Jerusalem, Israel
Unknown ^†	Mesenchymal Stem Cells as First Treatment Line for Resistant Acute Graft Versus Host Disease	Graft vs Host Disease	Biological: mesenchymal stem cells Drug: conventional treatment	Centro Terapia e Tecnologia Celular Porto Alegre, Rio Grande do Sul, Brazil
Terminated Has Results	Early Treatment of Acute Graft Versus Host Disease With Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids	Graft-Versus-Host Disease	Biological: MSC	National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland, United States
Completed	Treatment of Steroid Resistant GVHD by Infusion MSC	Graft-versus-host-disease	Biological: MSC (hPPL)	UMC Utrecht, department of pediatrics Utrecht, Netherlands UMCU department of Haematology Utrecht, Netherlands
Completed	Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease	Hematological Malignancies	Procedure: Mesenchymal stem cell infusion	CHU Sart Tilman Liege, Belgium
Withdrawn	Mesenchymal Stem Cells as a Treatment for Oral Complications of Graft-versus-host Disease	Graft -Versus-host-disease	Biological: Mesenchymal stromal cells	Oral and Maxillofacial Surgery, Karolinska Univeristy Hospital Stockholm, Huddinge, Sweden
Recruiting	Clinical Trial With MSC for Graft Versus Host Disease Treatment	Acute Graft Versus Host Disease	Drug: Adult Allogeneic Mesenchymal cells from adipose tissue.	Clinica Universitaria de Navarra, Av Pio XII ,36 Pamplona, Navarra, Spain Hospital Universitario Reina Sofía Córdoba, Spain Hospital Clínico Universitario Virgen de la Arrixaca Murcia, Spain (and 3 more…)
Completed	Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Patients	Graft Versus Host Disease	Drug: Prochymal (TM)	Duke University Durham, North Carolina, United States
No longer available	Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)	Graft-Versus-Host Disease	Drug: Prochymal®	Indiana BMT Beech Grove, Indiana, United States Dana Farber Cancer Institute Boston, Massachusetts, United States Memorial Sloan Kettering Cancer Center New York, New York, United States
Completed	Safety Study of Homeo-GH (Bone Marrow Derived Clonal Mesenchymal Stem Cell) to Treat Acute/Chronic Graft Versus Host Disease (GVHD)	Graft-vs-Host Disease	Drug: Homeo-GH	Inha University Hospital In Cheon, Korea, Republic of Seoul National University Hospital Seoul, Korea, Republic of Seoul St. Mary’s Hospital Seoul, Korea, Republic of Asan Medical Center Seoul, Korea, Republic of
Active, not recruiting	Evaluation of Umbilical Cord-Derived Wharton’s Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease	Acute Graft Versus Host Disease	Biological: MSCTC-0010 Dose Escalation	Kansas University Cancer Center Kansas City, Kansas, United States
Active, not recruiting	A Study of CYP-001 for the Treatment of Steroid-Resistant Acute Graft Versus Host Disease	Graft vs Host Disease	Biological: Mesenchymoangioblast-derived mesenchymal stem cells	Sydney Local Health District Sydney, New South Wales, Australia Royal Adelaide Hospital Adelaide, South Australia, Australia NHS Foundation Trust Bristol, United Kingdom (and 4 more…)
Unknown ^†	MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD	Acute Graft-versus-host Disease	Drug: CD25 monoclonal antibody Drug: calcineurin inhibitors Biological: MSCs	Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou, Guangdong, China
No longer available	Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD	Graft vs Host Disease Graft-Versus-Host Disease	Biological: remestemcel-L	Phoenix Children’s Hospital Phoenix, Arizona, United States Children’s Hospital of Orange County Orange, California, United States UCSF San Francisco, California, United States (and 24 more…)
Unknown ^†	Safety and Efficacy of UC-MSC in Patients With Acute Severe Graft-versus-host Disease	Acute GVH Disease	Biological: Human Umbilical Cord Derived MSC	Department of Hematopoietic Stem Cell Transplantation Beijing, China Department of Hematopoietic Stem Cell Transplantation, Affiliated Hospital to Academy of Military Medical Sciences Beijing, China
Recruiting	UCMSCs as Front-line Approach of Treatment for Patients With aGVHD	Acute-graft-versus-host Disease	Biological: Umbilical cord derived mesenchymal stem cell Other: Placebo	Hospital Ampang Ampang, Selangor, Malaysia
Completed	Donor Mesenchymal Stem Cell Infusion in Treating Patients With Acute or Chronic Graft-Versus-Host Disease After Undergoing a Donor Stem Cell Transplant	Cancer	Biological: graft versus host disease prophylaxis/therapy Genetic: fluorescence in situ hybridization Other: immunoenzyme technique (and 4 more…)	Geauga Regional Hospital Cleveland, Ohio, United States Lake/University Ireland Cancer Center Cleveland, Ohio, United States Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio, United States (and 5 more…)
Unknown ^†	Mesenchymal Stromal Cells (MSCs) for the Treatment of Graft Versus Host Disease (GVHD)	Graft vs Host Disease	Genetic: Mesenchymal stromal cells	U.O. Ematologia – Ospedali Riuniti di Bergamo Bergamo, BG, Italy Clinica Pediatrica CTMO – Azienda Ospedaliera San Gerardo Monza, MB, Italy U.O. Ematologia CTMO – Azienda Ospedaliera San Gerardo Monza, MB, Italy
Unknown ^†	Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells	Chronic Graft-Versus-Host Disease	Biological: Mesenchymal Stromal Cells	Xin Du Guangzhou, Guangdong, China
Unknown ^†	Mesenchymal Stromal Cells for Acute Graft Versus Host Disease	Acute GVH Disease	Biological: Mesenchymal stromal cell therapy	Royal Perth Hospital Perth, Western Australia, Australia
Completed	Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation	Acute Leukemia	Biological: Human umbilical cord blood-derived mesenchymal stem cells	Samsung Medical Center Seoul, Korea, Republic of
Recruiting	Effect of UMSCs Derived Exosomes on Dry Eye in Patients With cGVHD	Dry Eye	Drug: Umbilical Mesenchymal Stem Cells derived Exosomes	Zhongshan Ophthalmic Center Guangzhou, Guangdong, China
Recruiting	MSC for Severe aGVHD	Steroid-resistant Severe aGVHD	Biological: MSCs	Fujian Medical University Union Hospital Fuzhou, Fujian, China
Recruiting	Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease	Chronic Graft-versus-host-disease	Biological: SCM-CGH Other: Placebo	National Cancer Center Goyang-si, Gyeonggi-do, Korea, Republic of Inha University Hospital Incheon, Korea, Republic of Seoul National University Seoul Seoul, Korea, Republic of (and 4 more…)
Completed	Efficacy and Safety of Prochymal™ Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)	Graft Versus Host Disease	Drug: Prochymal Other: Placebo	University of Alabama Birmingham (UAB) Hospital Birmingham, Alabama, United States UCLA Medical Center Los Angeles, California, United States University of California Medical Center San Francisco, California, United States (and 50 more…)
Enrolling by invitation	Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders	Immune Related Disorder Tissue Damage	Biological: clonal fetal MSCs	Capital Institute of Pediatrics affiliated Children’s hospital Beijing, Beijing, China Shenzhen Geno-immune Medical Institute Shenzhen, Guangdong, China Aerospace Center Hospital Beijing, China
Completed	Mesenchymal Stem Cell Infusion in Haploidentical Hematopoietic Stem Cell Transplantation in Patients With Hematological Malignancies	Hematopoietic Stem Cell Transplantation	Biological: mesenchymal stem cells Drug: cyclophosphamide administration	Ankara University School of Medicine Department of Hematology Ankara, Turkey
Unknown ^†	Graft-versus-host Disease Associated Myelosuppression	Abnormal Hematopoiesis Allogenic Disease Graft vs Host Disease		Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden Dresden, Germany
Withdrawn	OTI-010 for Graft-Versus-Host Disease Prophylaxis in Treating Patients Who Are Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies	Graft Versus Host Disease Leukemia Myelodysplastic Syndromes	Biological: autologous expanded mesenchymal stem cells OTI-010 Drug: busulfan Drug: cyclophosphamide (and 4 more…)	Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California, United States
Recruiting	MSC and HSC Coinfusion in Mismatched Minitransplants	Leukemia, Myeloid, Acute Leukemia, Lymphoblastic, Acute Leukemia, Myelocytic, Chronic (and 6 more…)	Biological: Mesenchymal stem cells Other: Isotonic solution	UZA Edeghem, Antwerpen, Belgium St-Luc UCL Brussels, Brabant, Belgium AZ Gasthuisberg Leuven Leuven, Flamish Brabant, Belgium (and 7 more…)
Completed	A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD	Grade B aGVHD Grade C aGVHD Grade D aGVHD	Drug: remestemcel-L	Children’s Hospital Los Angeles Los Angeles, California, United States Children’s Hospital of Orange County Orange, California, United States University of California at San Francisco San Francisco, California, United States (and 29 more…)
Active, not recruiting	Intra-Osseous Co-Transplant of UCB and hMSC	Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia Myelodysplastic Syndromes (and 9 more…)	Drug: cyclophosphamide Drug: fludarabine phosphate Radiation: total-body irradiation (and 4 more…)	Case Comprehensive Cancer Center Cleveland, Ohio, United States
Terminated	Vismodegib in Treating Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease	Chronic Graft Versus Host Disease	Other: Laboratory Biomarker Analysis Drug: Vismodegib	University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan, United States Huntsman Cancer Institute/University of Utah Salt Lake City, Utah, United States

Clinical testing of MSC in GVHD

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Clinical testing of MSC in Graft Versus Host Disease (GVHD)